Granulation is a process for preparing agglomerates from powders such that the agglomerates can be further processed by compressing to form pharmaceutical dosage forms such as tablets. In the absence of granulation, many active ingredient containing powders would not be able to be compressed into tablets having acceptable friability.
Wet granulation is a widely used method of granulation used in tablet and capsule manufacture. Hot melt granulation employs a molten binder to form agglomerates. However, when tablet or capsule ingredients are sensitive to moisture or are unable to withstand elevated temperatures, dry granulation may be employed. In any case, the granules once formed must possess physical characteristics required for the formulation to be compressed into a tablet.
However, it is difficult to combine certain active ingredients with the excipients needed to form granules without also affecting the release profile of the active ingredient from the final formulation containing the granules. The following disclosure addresses this shortcoming of the art.